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| |  Studies Support the Long-Term Use of Risperdal SAN DIEGO, May 21, 1997 -- Risperdal(R) (risperidone), the most prescribed antipsychotic in the United States, is associated with a low incidence of side effects commonly associated with many antipsychotic medications, according to data from studies analyzing experience with thousands of Risperdal patients. The studies were presented today at the annual meeting of the American Psychiatric Association. These side effects include extrapyramidal symptoms (EPS), tardive dyskinesia, prolactin-related adverse events and cardiovascular symptoms. "This exhaustive real-world research confirms and extends Risperdal's track record and favorable side effect profile in more than three million patients worldwide," said Martin Brecher, M.D., director of CNS Medical Development at the Janssen Research Foundation (1). "We're noticing that in common clinical practice, 4 mg per day is an effective target dose, with some patients requiring doses up to 6 mg per day." -- Extrapyramidal Symptoms (EPS), Tardive Dyskinesia An analysis presented in a poster session by Brecher et al of 12 double-blind studies involving 2,074 patients demonstrated that the incidence of EPS was comparable among patients receiving placebo and patients receiving Risperdal at recommended doses of 6 mg per day or less. Accordingly, fewer patients on these doses of Risperdal needed adjunctive medications to control EPS, which include muscle stiffness, rigidity, uncontrollable tremors, involuntary movements and restlessness. Patients commonly say that EPS is the reason why they stopped taking antipsychotic medications. In addition, only four cases of tardive dyskinesia were reported among more than 1,100 Risperdal patients in long-term trials, as presented by Brecher et al in their poster session. Tardive dyskinesia (TD) is a serious disorder common in patients treated with traditional antipsychotic drugs for schizophrenia. TD is characterized by involuntary movements that most often affect the mouth, lips and tongue. -- Serum Prolactin Levels Kleinberg et al presented an analysis of four studies comparing Risperdal with placebo or an active control found that Risperdal was not related significantly to adverse events caused by prolactin elevation. This data, from 1,023 patients, also showed that the differences in prolactin-related adverse events among the three groups were not significant. Elevated prolactin, or hyperprolactinemia, is a common clinical disorder that may lead to sexual dysfunction, breast enlargement (in women or men) and breast milk secretion in the absence of nursing. -- Electrocardiogram (ECG) Abnormalities Another review by Brecher et al of ECGs of patients who participated in any of three short-term (N=1,885) or seven long-term (N=1,156) trials with Risperdal showed no clinically significant changes in the QTc intervals. This abnormality, which occurs when the heart's electrical current recharges, is an important consideration due to its possible association with certain cardiac events. "The low EPS and cardiovascular risk associated with Risperdal makes it a desirable therapeutic option for elderly patients," noted Carlos Zarate, Jr., M.D., assistant professor of psychiatry, Harvard Medical School and director of the Bipolar and Psychotic Disorders Outpatient Service, McLean Hospital. "Elderly patients often have coexisting medical diseases that require the use of medications. In fact, more than 75 percent of the elderly patients in our study had cardiovascular disease, and no significant cardiac complications were observed during Risperdal therapy." Clinical studies have shown that the incidence of extrapyramidal symptoms with Risperdal, while dose dependent, is comparable to placebo at recommended doses. The most common side effects reported in clinical trials were insomnia, agitation, EPS, headache, anxiety and rhinitis; less common were somnolence, dizziness, constipation, nausea and tachycardia. Risperdal may also cause orthostatic hypotension, a form of intermittent low blood pressure, especially during the initial dosing period. Janssen Pharmaceutica, a Johnson & Johnson company, is headquartered in Beerse, Belgium and has affiliates in 32 countries. U.S. headquarters are in Titusville, N.J.
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